TITAN™ Reverse Shoulder System

Study Purpose

The Integra® TITAN™ Reverse Shoulder System (TRS) is a semi-constrained total shoulder construct. When used under the conditions and purposes intended the TRS will relieve pain and restore some functional joint motion to the affected shoulder. The purpose of this study is to assess the short, mid and long term outcomes of the TITAN™ Reverse Shoulder System.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	21 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Subjects with grossly deficient rotator cuff with severe arthropathy or Subjects with failed joint replacement with grossly deficient rotator cuff - Subjects with a shoulder joint anatomically and structurally suited to receive the device - Subjects at least 21 years of age and skeletally mature at the time of surgery - Subject provided consent to participate in the clinical study (having signed the Informed Consent Form)

Exclusion Criteria:

- Subjects without a functional deltoid muscle - Subjects with active local or systemic infection - Subjects with inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components - Subjects with poor bone quality such as osteoporosis where there could be considerable migration of the prosthesis and/or a chance of fracture of the humerus or glenoid - Subjects with muscular, neurologic, or vascular deficiencies that compromise the affected extremity - Subjects with known metal allergies - Subjects are known to be at risk for lost to follow-up, or failure to return for scheduled visits - Subjects who are prisoners - Female subject who are pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02204228
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Integra LifeSciences Corporation
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Andrew Tummon
Principal Investigator Affiliation	Integra LifeSciences
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	France, Spain, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Osteoarthritis of the Shoulder

Arms & Interventions

Arms

: TITAN™ Reverse Shoulder System (TRS)

TITAN™ Reverse Shoulder System (TRS) is a semi-constrained total shoulder construct.

Interventions

Device: - TITAN™ Reverse Shoulder System (TRS)

All patients will be operated on with the TITAN™ Reverse Shoulder System (TRS).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Florida, Gainesville, Florida

Status

Recruiting

Address

University of Florida

Gainesville, Florida, 32607

Site Contact

Aimee Struk

[email protected]

352-273-7419

Johns Hopkins University, Columbia, Maryland

Status